Intravenous drug access system

ABSTRACT

An intravenous drug access system. In one embodiment of the invention, the drug access system includes an IV bag having an inlet port and an outlet port, whereby the inlet port is a female luer integral therewith. The integral female luer fitting may be fitted with a sealed end cap including a male luer insert with a closed end. An alternative embodiment of the present invention comprises a discrete pre-molded connector made with a spike at one end and a female luer fitting at the opposing end. The spike is used to penetrate a standard IV bag through a conventional inlet port.

This application is a continuation of U.S. application Ser. No.09/161,942, filed Sep. 28, 1998, now abandoned, which is incorporatedherein by reference.

FIELD OF THE INVENTION

The invention relates to the field of fluid transfer devices and, morespecifically, to a novel intravenous drug access system.

BACKGROUND OF THE INVENTION

The manipulation of fluids for administration to a patient in hospitaland medical settings involves the use of drug access systems thattypically include a sealed inflatable container, commonly referred to asan intravenous (IV) bag. The IV bag is used to store a primary liquidsuch as plasma, blood, saline, or other types of medicinal solutions.When fluids are to be introduced into a patient intravenously, an IV bagis suspended above the patient on a portable hanger stand. Through aseries of tubes and connectors, the fluid within the IV bag is deliveredfrom the IV bag to the patient.

FIG. 1 illustrates a partial perspective view of a traditional IV bag100. The IV bag includes a sealed inlet or injection port 102 and anoutlet port 104 for the transfer of fluids to and from the IV bag,respectively. The inlet port 102 permits the introduction of a secondaryfluid, such as a drug, into the IV bag, for mixing with the primaryfluid. The outlet port 104 permits the transfer of the primary solutionin the IV bag to the patient via tubes and connectors.

To seal the contents of the bag, the inlet port 102 typically includes aseptum 106 compressively affixed within the interior opening of theinlet port to prevent the flow of fluid out of the bag. The septum 106may be of continuous construction or made with a pre-fabricated slitthat remains closed until penetrated. In either case, the septum issufficiently resilient so as to permit penetration of the septum with asharp device such as a syringe needle for the transfer of fluids intothe IV bag.

Another example of a sharp device for penetrating a septum within aninlet port is a spiked connector. One type of spiked connector is adual-spiked connector comprising a housing having a conduit extendingfrom one spike to the other. The first spike is open-ended, in which theconduit communicates with the ambient. The second spike, at the oppositeend of the connector, is closed such that the conduit is not incommunication with the ambient. This closed-end tip is designed to breakaway and is used to penetrate the IV bag through the inlet port. At thefirst end, the open-ended spike is used to penetrate a drug vialcontaining a secondary fluid. By placing this dual-spiked connectorbetween a drug vial and the W bag, a secondary fluid can be introducedinto the IV bag and mixed with the primary fluid therein.

As a discrete pre-fabricated component, such a dual-spiked connectordoes not permit fluid flow therethrough because at least one spikeincludes a closed, break-away tip. However, upon penetration of theclosed spike tip through the inlet port of the IV bag, fluidcommunication between the secondary fluid container and the bag may beestablished by breaking off the break-away tip while the tip is withinthe interior of the IV bag. Once the tip is broken, the conduit of theconnector permits the flow of fluid in the internal fluid conduit fromthe drug vial to the interior of the IV bag. Disadvantageously, thebreak-away tip floats in the IV bag during the administration of theprimary and secondary fluids to the patient through the outlet port.Should the break-away tip become lodged in the outlet port of the IVbag, the flow of the primary and secondary fluids to the patient may bestopped or dramatically reduced, endangering the health of a patient.Moreover, because the mixed solution in the IV bag is visible to thepatient, the existence of the floating foreign object (spike tip) in thefluid may be psychologically troubling to the patient.

Another type of dual-spiked connector for introducing a secondary fluidinto an IV bag is one that eliminates the break-away tip. With thisalternative connector, the conduit is in communication with the ambientat both spiked ends. Instead of a breakaway tip, however, thisalternative connector employs a plug centrally positioned within theinternal conduit to prevent the flow of fluid therethrough until themedical practitioner so desires. After both spikes of the connector arein place, i.e., both have penetrated their respective medicalcontainers, the medical practitioner applies an external compressiveforce to the plug by squeezing the IV bag. The force applied dislodgesthe plug, whereby the plug is forced into the secondary fluid container(drug vial).

The use of a push-away plug also presents problems. For example, it hasbeen proven difficult, if not costly, to manufacture a conduit plug thatreliably performs as designed. If the conduit plug is made too small,the plug does not exert sufficient frictional force against the interiorwalls of the internal conduit. Under those circumstances, the ambientpressure from the primary fluid itself may dislodge the primary plugprematurely, causing leakage of fluid intended for a patient.Alternatively, if the conduit plug is too large, the compressive forcethat is necessary to dislodge the plug is too great. Under thosecircumstances, the force applied externally to the IV bag may adverselycompromise the structural integrity of the bag, again causinglife-sustaining fluid to leak.

With either of the above connectors, an inherent problem exists in thatonce fluid flow is established, it cannot be stopped. That is becauseneither connector is adapted to control the fluid flow therethrough.Moreover, the configuration of the connectors is such that afluid-control valve cannot be readily attached to the exposed spike endof the connector. Valves that exist to control the flow of medicinalfluids into an IV bag, such as that shown in U.S. Pat. No. 5,694,686,have male luer fittings that are not designed to connect to a spike(e.g. the CLAVE® 1000 connector manufactured by ICU Medical, Inc. of SanClemente, Calif. or the pre-slit Injection Site manufactured by McGawInc. of Irvine, Calif.) Thus, a device to permit an IV bag to be placedin fluid communication with a wide range of commercially availableconnectors is needed.

Another problem with the connectors identified above is thatmanufacturing costs are high. Typically, the connectors are injectionmolded. To generate the interior conduit of the connector housing, acore pin is used to define the surface of the interior conduit. Due tothe extremely high temperatures used in the molding process, there is atendency of the core pin to float within the liquified housing materialduring the molding process, creating non-uniform wall thickness, whichis unacceptable. Thus, the rejection rate is high, driving up the costsof manufacture.

There is, therefore, a need for a drug access system configured toeliminate break-away or floating parts, to reduce the cost of partmanufacture, and to expand the use of connectors to which an IV bag maybe attached.

SUMMARY OF THE INVENTION

The drug access system of the present invention has several features, nosingle one of which is solely responsible for its desirable attributes.Without limiting the scope of this invention, as expressed by the claimswhich follow, its more prominent features will now be discussed briefly.

The present invention is an intravenous drug access system. In oneembodiment of the invention, the drug access system includes an IV baghaving an inlet (injection) port and an outlet port, whereby the inletport is a female luer fitting integral with the IV bag. With a femaleluer fitting integral with the IV bag, any number of one-way valves orneedleless syringes may be connected to the female luer fitting tofacilitate and control the flow of fluid into or out of the IV bag. Witha one-way valve connected to the female luer, the IV bag of the presentdrug access system may be filled with primary fluid and shipped to theend user for later introduction of a secondary fluid. In thisembodiment, breakaway parts and/or push-away plugs are advantageouslyeliminated.

Where it is desired that the IV bag be filled and shipped without aone-way valve already attached thereto, the integral female luer fittingmay be enclosed with a sealed end cap comprising a male luer insert witha closed end. Upon receipt by the end user, the IV bag may be turnedupside down to isolate the inlet port away from the contents of the IVbag so that the end cap may be removed and replaced by any valve orconnector chosen by the end user. In a variation of this embodiment, thefemale luer fitting may include a thin, membrane stretched across theopening of the female luer fitting to prevent the flow of fluidtherethrough. It is contemplated that the membrane be readily penetrableby the application of a male luer fitting of a valve by the end userwhen desired. With this latter variation, no end cap is required and theIV bag need not be turned upside down to connect the valve thereto.

The advantage of an integral female luer with an IV bag is that iteliminates the need for a costly conventional dual-spiked connector.However, if a user would prefer to receive IV bags that haveconventional inlet ports, an alternative embodiment of the presentinvention comprises a discrete pre-fabricated connector made with onespike at one end and a female luer fitting at the opposing end. Thespike is used to penetrate the IV bag through the conventional inletport, as with the prior art connectors. Instead of having a secondspike, however, an integral female luer is provided that permitsconnection to a one-way valve or needleless syringe, or any otherconnector having a male luer fitting. In one variation of this secondembodiment, the improved connector includes a protective flange thatsurrounds, at least in part, the spike to prevent the spike frominadvertently coming into contact with other objects and becomingcontaminated when the connector is not in use. In addition, the flangeprevents the spike from piercing the skin of a healthcare worker.

There are additional advantages to this second embodiment. In themolding process of the prior art connectors, there were high rejectionrates, as explained above. With a connector having a female luer fittingat one end, instead of a second spike, the core pin may be moreeffectively secured, reducing the likelihood of the core pin floatingduring the molding process. This results in a reduction in the cost ofmanufacture, when compared to the molding of prior art connectors.Unlike the prior art connectors, the spike contemplated in the secondembodiment of the present invention need not be a closed tip spike. Inother words, the spike can be open-ended, permitting immediate backflowof the primary fluid in the IV bag into the interior conduit of theinventive connector. In that instance, the female luer fitting at theother end may be provided with an end cap or thin membrane, as describedabove, to prevent the fluid from leaking. Upon the connection of aone-way valve or a needleless syringe, fluid flow may be establishedbetween a secondary fluid source and the IV bag.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a conventional intravenous bag thathouses fluids for introduction into patients.

FIG. 2 is an elevational sectional view of a first embodiment of thepresent invention.

FIG. 3 is an elevational sectional view of the first embodiment of FIG.2 shown with a needleless valve in fluid communication therewith shownin partial cross-section.

FIG. 4 is an elevational sectional view of the second embodiment of thepresent invention.

FIG. 5 is an elevational sectional view of the second embodiment of FIG.4 shown applied to an IV bag and a valve shown in partial cross-section.

FIG. 6A is an elevational sectional view of a variation of the secondembodiment of FIG. 4, illustrating an integral seal.

FIG. 6B is an elevational sectional view of the embodiment of FIG. 6A,illustrating the integral seal compressed by a male luer connector.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following detailed description is directed to certain specificembodiments of the invention. However, the invention can be embodied ina multitude of different ways as defined and covered by the claims. Inthis description, reference is made to the drawings wherein like partsare designated with like numerals throughout.

As discussed above, FIG. 1 shows a conventional IV bag having inlet andoutlet ports for the transmission of fluids into the IV bag and to thepatient, respectively. FIG. 2 illustrates a first embodiment of the drugaccess system 200 of the present invention, which is an improvement overthe prior art IV bag. The inventive drug access system 200 comprises acollapsible container 202, such as an IV bag, that includes at least oneintegral inlet (injection) port 204 and at least one integral outletport (not shown). The inlet port 204 comprises a housing 206 made of,e.g., a hard durable plastic, metal, or any other material known tothose of skill in the art. The port 204 defines an internal conduit 208for allowing fluid communication between the IV bag 202 and a discreteconnector or valve. The housing 206 has a female fitting at a distalend, commonly referred to as a female luer, for acceptance of a maleluer therein. Preferably, the housing 206 includes external threads 210for mating with a male luer lock. The female luer inlet port 204 may bemade integral with the IV bag 202 by methods known in the art ofmanufacturing IV bags.

To seal the contents of the IV bag 202, a male luer cap 214 may be used.The male luer cap 214 consists of a housing 216 defining a solid plug218 that fits within the interior conduit 208 of the female luer inletport 204. Preferably, the male luer cap 214 includes an annular collar222 having internal threads 224 for mating with the threads 210 of thehousing 206. If desired, the interior conduit 208 and the correspondingmating plug 218 may be tapered to permit a more snug fit. Upon receiptby the end user, the IV bag 202 may be turned upside down, as will beunderstood by those skilled in the art, in order to isolate the inletport 204 away from the contents of the IV bag 202. At that point, theuser may remove the end cap 214 and replace it with a valve or connectorhaving a male luer.

In one variation of this embodiment, the housing 206 may come fittedwith a thin membrane made of, e.g., latex (not shown) across an opening212 of the internal conduit 208 to prevent the flow of fluidtherethrough. It is contemplated that the thin membrane be readilypenetrable by the application of a mating male luer of a valve orneedleless syringe by the end user when desired. In a second variation,a compressible seal (not shown) may be provided within the opening 212of the housing 206, wherein the seal has a pre-fabricated slit thereinthat remains closed until the seal is compressed by the application of amale luer into the opening 212. With these latter variations, no cap isnecessary and the IV bag 202 need not be turned upside down to connectthe valve thereto. The membrane and seal may be manufactured by knownmethods used by those of skill in the industry.

Once the male luer cap 214 is removed, the female luer inlet port 204 ofthe IV bag 202 may be advantageously mated with various male luerconnectors or valves. For example, referring to FIG. 3, the IV bag 202may be mated to a needleless valve 300, such as the CLAVE® 1000connector manufactured by ICU Medical, Inc. of San Clemente, Calif. Afirst, proximal end 302 of the needleless valve 300 includes a male luerfitting 306 for mating with the female luer inlet port 204 of the IV bag202. The needleless valve 300 may be provided with an annular collar 308having internal threads 304 to mate with the external threads 210 of thefemale luer inlet port 204. An internal conduit 310 extends through thevalve. A second, distal end 312 of the needleless valve 300 preferablyincludes a seal (not shown) that encloses an opening at the distal endfrom the internal conduit to the ambient. The seal prevents the flow ofliquid through the valve until a male luer connector (not shown) ismated to the second, distal end 312 of the needleless valve 300. Theconnection of a male luer connector to the distal end 312 of the valveexposes the opening to permit fluid therethrough, as described ingreater detail in U.S. Pat. No. 5,694,686 to Lopez, incorporated hereinby reference. Once the needleless valve 300 is connected to the femaleluer inlet port 204, a sealed fluid pathway is created, as will beunderstood by those of skill in the art.

It is contemplated that any number of valves or connectors may beconnected to the female luer inlet port 204 of the IV bag 202 ofintravenous drug access system 200. For example, the female luer inletport 204 may be mated with a pre-slit Injection Site connector having amale luer fitting. The pre-slit Injection Site connector may include aseptum, such as an elastomeric plug, to act as a seal. The septum can bepenetrated by a sharp piercing member such as a cannula, a syringe, orother medical implement. As with a needleless valve, the use of apre-slit Injection Site connector advantageously permits a user tocontrol the flow of liquid to or from the IV bag 202.

With reference to FIGS. 4 and 5, a second embodiment of the inventioncomprises a connector 500 for providing fluid communication between amedical connector or valve 600 and an IV bag 402 having a conventionalsealed inlet (injection) port 404. The inlet port 404 of the IV bag 402includes a conventional septum 406 within the interior of the inlet port404 to prevent the flow of fluid out of the IV bag 402. An annularlocking member 408 extends radially from a midsection of the inlet port404. The annular locking member 408 may be used to lock a valve orconnector to the inlet port 404, as described in further detail below.

Preferably, the medical connector 500 includes a main housing 514 thatis preferably integrally molded from a suitable plastic material, suchas polycarbonate, although other medically inert materials may be used.The housing 514 defines an internal fluid conduit 518 having a first,proximal end with a spike or puncture member 526. The spike 526 isconfigured for piercing or spreading apart the sealed inlet port 404 ofthe IV bag 402. The spike 526 preferably includes a sharp tip 530 havingat least one aperture 532 near or at the tip 530 of the spike 526. Theaperture 532 permits fluid from the conduit 518 to the IV bag 402. Theaperture 532 is preferably open to the ambient, although a removableclosure feature, such as a break-away tip or a push-away plug, is alsocontemplated.

A second, distal end 536 of the connector 500 preferably defines afemale fitting, such as a female luer 538. The female luer 538 iscontemplated to be configured as described above in association with thefirst embodiment of the present invention. As with the female luerfitting of the first embodiment (FIG. 3), the female luer fitting of thepresent invention connector 500 may also be mated with a valve 600having a male luer 602 (FIG. 5). The desired connection is as describedabove in association with FIG. 3. Alternatively, a pre-slit InjectionSite connector or a needleless syringe may be mated with the connector500 in lieu of a needleless valve. Any valve or connector that has amale luer may be used in connection with the medical connector 500.

Preferably, the housing 514 also includes an interlocking coupling 542for use in locking the connector 500 to the standard inlet (injection)port 404. It is contemplated that the interlocking coupling 542comprises resilient fingers 544 that snap over the annular lockingmember 408 of the inlet port 404. At the end of each finger 544 is a lipthat extends inward to provide a seat for the annular locking member 408of the inlet port 404. Preferably, there are at least three fingers 544of the interlocking coupling 542. As the medical connector 500 isdirected toward the IV bag 402, the annular locking member 408 bearsagainst the ends of the fingers 544, pushing them outward. After theannular locking member 408 has passed the lips of each finger, thefingers return to their normal position for a snap fit. At that point,the spike 526 has penetrated the septum 406 of the inlet port 404 toestablish fluid connection therewith.

It is also desirable that an annular protective collar 550 surround thespike 526 to prevent contact of the spike with a contaminated surfaceprior to use. The protective collar 550 further reduces the risk thatmedical personnel are injured by exposure to the spike 526. Theprotective collar may comprise discrete flanges 552 arranged radiallyabout the spike 526. Preferably, the protective flanges 552 extendaxially past the termination point of the spike 526, thereby allowingthe connector 500 to be placed on a resting surface, if desired. Whenapplied to an IV bag, the protective collar 550 straddles the base ofthe IV bag 402, as shown in FIG. 5. Thus, the IV bag 402 is positionedbetween adjacent flanges 552 of the collar 550. Of course, it will beunderstood by one of skill in the art that it is not necessary to havean annular protective collar at all, if so desired.

In a variation of this embodiment, the fingers 544 of the interlockingcoupling 542 may be made integral with the protective flanges 552instead. In that variation, each flange has at least one fingerextending inwardly therefrom for locking engagement with the annularlocking member 408 of the inlet port 404.

If the medical connector 500 is to be connected to the IV bag 402, whichhas been shipped pre-filled with a fluid, it is recommended that aneedleless valve 600, such as the CLAVE® 1000 connector, be affixed tothe second end 536 of the medical connector 500. Other valves orclosures having a male luer fitting may also be used, as will beunderstood by those of skill in the art.

A further variation of the embodiment of FIGS. 4 and 5 is shown in FIGS.6A and 6B. In FIG. 6A, the connector 500 is all respects the same,except that the interior conduit 518 at the distal end 536 is configuredto accept a conventional septum (not shown) or an integral, penetrableseal 560. In this embodiment, the interior conduit 518 at the distal end536 is tapered to form a smaller diameter section 564 and a largerdiameter section 568 spaced inwardly therefrom. The seal 560 is affixedto interior conduit 518 at the larger diameter section 568, preferablywithin an annular groove 570, and extends outwardly toward the outlet ofthe distal end 536. The seal 560 includes a pre-fabricated slit 572 thatremains closed at its distal end when it is compressed within thesmaller diameter section 564 of the interior conduit 518. Uponapplication of a male luer connector 576 (FIG. 6B) into the female luer538 of the connector 500, the seal 560 is pushed inwardly so that theslit 572 is permitted to expand to an open position within the largerdiameter section 568. When the slit 570 opens, upon application of themale luer 576 within the female luer 538, fluid communication ispermitted therethrough.

While the above detailed description has shown, described, and pointedout novel features of the invention as applied to various embodiments,it will be understood that various omissions, substitutions, and changesin the form and details of the device or process illustrated may be madeby those skilled in the art without departing from the spirit of theinvention. The scope of the invention is indicated by the appendedclaims rather than by the foregoing description. All changes which comewithin the meaning and range of equivalency of the claims are to beembraced within their scope.

What is claimed is:
 1. A medical connector for use in transferringfluids to a drug access bag having at least one inlet port, the medicalconnector comprising: a housing having a first and second end eachterminating an internal conduit defined therein; a puncture member atthe first end of the housing adapted to be inserted into the inlet portto permit fluid transfer between said bag and said connector; a femaleluer fitting at the second end of the housing for mating with acorresponding male luer fitting of a discrete connector or valve; and aprotective flange surrounding at least a portion of the puncture memberto minimize contamination of said puncture member due to inadvertentcontact with contaminated surfaces, wherein the protective flangecomprises two discrete portions configured to straddle the drug accessbag.
 2. The medical connector of claim 1, wherein the female luerincludes external threads surrounding said luer to form a luer lock, andthe connector further comprises an interlocking coupling disposedbetween the protective flange and the puncture member adapted to attachthe connector to an inlet port on a drug access bag.
 3. The medicalconnector of claim 2, wherein the valve is a needleless valve.
 4. Themedical connector of claim 3, wherein the female luer includes aprotective membrane to seal the contents of the bag therein, saidmembrane being penetrable by the application of a male luer into saidfemale luer.
 5. The medical connector of claim 4 further comprising amale luer end cap adapted to sealably enclose the female fitting.
 6. Themedical connector of claim 5 further comprising a coupling integral withthe housing to receive and retain at least a portion of the inlet port.7. The medical connector of claim 3, wherein the needleless valvecomprises a cavity with a resilient seal disposed therein, the sealbeing adapted to be moved to a compressed position to permit fluid flowthrough the valve upon insertion of a medical implement, and the sealbeing adapted to resiliently return to an uncompressed position andobstruct fluid flow upon removal of the medical implement.
 8. Themedical connector of claim 1 in combination with a drug access systemcomprising a bag adapted to contain medicinal fluids having an inletport and an outlet port, said outlet port configured to transfer saidfluids to a patient, said inlet port constructed integral with said bagand adapted to receive fluids therethrough for introduction into saidbag, said inlet port being further configured to sealably connect to themedical connector, said inlet port comprising a housing defining aninternal conduct for fluid communication between said medical connectorand said bag.
 9. The combination of claim 8 wherein the inlet portfurther comprises external threads surrounding said female luer end toform a luer lock.
 10. The combination of claim 9 wherein the female luerincludes a protective membrane to seal the contents of the bag therein,said membrane being penetrable by the application of a male luer intosaid female luer.
 11. The combination of claim 10 further comprising amale luer end cap adapted to sealably enclose the female luer.
 12. Themedical connector of claim 1, wherein said puncture member comprises aspike having a tip and at least one aperture at or near said tip.